Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
29/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Karl Harvey

ORCID ID

Contact details

Cancer Research UK Liverpool Cancer Trials Unit
200 London Road
Liverpool
L3 9TA
United Kingdom

Additional identifiers

EudraCT number

2010-019575-29

ClinicalTrials.gov number

Protocol/serial number

9888

Study information

Scientific title

Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (NCRI CLL210)

Acronym

CLL210 (CamDexRev)

Study hypothesis

All patients will receive induction therapy for 24 weeks with alemtuzumab, dexamethasone and lenalidomide (CamDexRev). Patients with stable or progressive disease (SD/PD) will receive no further trial treatment and will be managed at the discretion of local investigator. Patients who achieve a CR or PR may elect to have an allogeneic stem-cell transplant. Those responders who decide not to have a transplant will be randomised between continuing lenalidomide until disease progression or receiving no further trial treatment.
Objectives:
Primary:CR rate after 6 months of induction therapy
Progression-free rate after 2 years of maintenance therapy, defined as the proportion of patients who are progression free and alive at 2 years
Secondary
Overall, complete and partial response rates following induction therapy
Minimal residual disease (MRD) negativity rate following induction therapy
Overall survival (time from start of study treatment to death)
Progression-free survival (time from initiation of study treatment to progression or death)
Time to treatment failure (time from initiation of study treatment to treatment failure defined as progression, death or initiation of alternative treatment due to failure to achieve CR or PR)
Duration of response (time from first achievement of CR or PR to first time of progression or death)
Toxicity
Quality of life
Descriptive summary of Progression-free and overall survival among transplant-eligible patients
These will be estimated separately for the induction and the randomised phases of the study.

Ethics approval

ref: 11/H1005/10

Study design

Both; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Leukaemia

Intervention

Induction phase: Alemtuzumab, Subcutaneous, 30mg od on days 1, 3 and 5 of weeks 7-22
Induction phase: dexamethasone, Taken orally, 40mg od, day 1-4 of weeks 1, 3, 5, 7, 9, 11, 13 and 15.
Induction phase: Lenalidomide, Taken orally, 5mg od, days 1-7 on weeks 3-4 and 10mg od, days 1-7 of weeks 5-24.;
Induction phase: Lenograstim, Subcutaneous, 263µg od, days 1, 3 and 5 on weeks 5-8 plus whenever neutrophils <1.0x10^9/l;
Maintenance: Lenalidomide, 10mg, od until disease progression; Follow Up Length: 30 month(s); Study Entry : Registration and One or More Randomisations

Intervention type

Drug

Phase

Phase II

Drug names

Alemtuzumab, dexamethasone, lenalidomide

Primary outcome measures

1. Complete response (CR)
2. Complete response with incomplete blood count recovery (CRi) rate after 6 months

Secondary outcome measures

1. Progression-free rate after 2 years of maintenance therapy, defined as the proportion of patients
2. Toxicity
3. Cumulative dose of individual drugs administered
4. Overall, complete and partial response rates
5. Minimum Residual Disease (MRD) negativity rate
6. MRD-negative CR rate
7. Overall survival
8. Progression-free survival (progression or death)
9. Event-free survival (progression, death or further induction treatment)
10. Response duration
11. Quality of life

Overall trial start date

01/09/2011

Overall trial end date

01/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. CLL/SLL requiring treatment by IWCLL 2008 criteria
2. At least one of the following criteria should be met:
2.1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
2.2. Massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
2.3. Massive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy
2.4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months from a baseline value of at least 30x109/l and not due to causes other than CLL.
2.5. Constitutional symptoms defined as at least 10% unintentional weight loss within the previous 6 months, significant fatigue preventing usual activities, or fever of at least 38°C for at least 2 weeks or night sweats for at least one month in the absence of infection
3. High risk CLL/SLL defined by at least one of the following criteria:
3.1. TP53 deletion or mutation affecting at least 20% of CLL cells
3.2. Resistant (SD/PD) to fludarabine-containing combination therapy
3.3. Relapse within 12 months of responding to fludarabine-containing combination therapy
3.4. No prior treatment with alemtuzumab or lenalidomide
4. CLL not known to be resistant to glucocorticoids
5. No more than 3 previous treatment episodes for CLL
6. WHO performance status 0-2
7. Aged at least 18 years
8. Written informed consent
9. Male and female participants
10.Lower age limit 18 years, no age limit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 85; UK Sample Size: 85

Participant exclusion criteria

1. Neutrophil count less than 0.5x109/l or platelet count less than 25x109/l
2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
3. Active infection
4. Active gastritis or peptic ulcer disease
5. Uncontrolled diabetes mellitus or hypertension
6. History of recurrent thromboembolism
7. Seropositivity for HIV, HCV or HBV (surface antigen or core antibody)
8. Renal impairment (creatinine clearance less than 30ml/min)
9. Hepatic impairment (serum bilirubin more than twice the upper limit of normal unless due to Gilbert's syndrome or CLL)
10. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg
11. Presence or history of CNS disease (either CNS lymphoma or leukaemic meningitis) 12. History of Richter transformation
13. Allergy to rat proteins
14. Concomitant malignancies except adequately treated localised non-melanoma skin cancer and cancers that have been in remission for at least 5 years
15. Major surgery within 28 days prior to registration
16. Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
17. Treatment within a clinical trial within 30 days prior to trial entry
18. Adult patient under tutelage (not competent to sign informed consent)
19. Pregnant or lactating women
20. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
21. Women taking the oral contraceptive pill within 4 weeks of study registration owing to an increased risk of thromboembolism

Recruitment start date

01/09/2011

Recruitment end date

01/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Liverpool Cancer Trials Unit
Liverpool
L3 9TA
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Cancer Research UK
Liverpool Cancer Trials Unit
200 London Road
Liverpool
L3 9TA
United Kingdom

Sponsor type

University/education

Website

http://www.liv.ac.uk/

Funders

Funder type

Industry

Funder name

Celgene International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chugai Pharma (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/02/2016: No publications found, verifying study status with principal investigator.